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gineco ro gynecology or somatic symptoms during the 5 days before menses in each of the three prior menstrual cycles. In PMDD there must be at least five symptoms for most of the menstrual cycles during the past year 7 . The diagnostic criteria for PMDD proposed in DSM-IV-TR request that five or more of the following symptoms must be present: n depressed mood; n anxiety, tension; n anger or irritability; n difficulty in concentrating; n lack of interest in activities once enjoyed; n lethargy, easy fatigability; n moodiness; n increased appetite; n insomnia or hypersomnia; n feeling overwhelmed or out of control; n other physical symptoms. Somatic symptoms may include edema, breast tenderness or swelling, bloating, joint or muscle pain, weight gain, syncope and headaches 1 . Some authors consider that PMDD symptoms may be of comparable severity to those of major depressive disorder (MDD) and cause a marked impairment in functioning in the week prior to menstruation 8 . The difference between PMDD and MDD is that PMDD symptoms are subsiding with onset of menses. There is also an important overlap between the symptoms of anxiety disorders and PMDD, which is reported in certain studies and raises questions as if there are shared underlying biological abnormalities 9-10 . Premenstrual dysphoric disorder is considered a somatopsychic illness triggered by the changing levels of sex steroids that accompany an ovulatory menstrual cycle 7 . Current research implicates mechanisms of serotonin as relevant to etiology and treatment 11-17 . Patients with mild to moderate symptoms of premenstrual syndrome (PMS) may benefit from nonpharmacologic interventions such as education about the disorder, lifestyle changes and nutritional adjustments 18-20 , but patients with premenstrual dysphoric disorder (PMDD) and those who fail to respond to more conservative measures may also require pharmacologic management. Selective serotonin reuptake inhibitors (SSRIs) are the first-line treatment for PMDD 11-17 . This drug class reduce emotional, cognitivebehavioural, and physical symptoms, and pag. 254 improve psychosocial functioning. As SSRIs, sertraline, fluoxetine and paroxetine (as an extended-release formulation) are approved by the Food and Drug Administration (FDA), for luteal phase, as well as continuous administration 11,13-17 . Escitalopram is a more recent SSRI (closely related with citalopram) and is approved in Romania for the treatment of depressive and anxiety disorders. It is used off-label for other disorders, including premenstrual dysphoric disorder 21 , which is included, as discussed, in depressive disorders. Method study objectives The primary objective of this study was to assess the efficacy of daily treatment throughout the menstrual cycle with escitalopram (20 mg/day) after 3 cycles of treatment. The secondary objective of the study was to assess the tolerability of treatment with escitalopram. The main scale used was the Visual analogue scale revised (VASs) 22-23 . The primary efficacy variable was the change in the mean luteal phase VAS-Mood scores from baseline to end of treatment cycle 3 22-23 . Secondary outcome measures included change from baseline to treatment in the sum of the 11 VAS symptoms (VAS-Total) and change from baseline in mean luteal phase VAS physical symptoms (last item). We also evaluated the proportion of patients showing response, the proportion of patients in remission, the mean change from baseline in the Montgomery Åsberg Depression Rating Scale (MADRS) 24 , the mean change in the Clinical Global Impressions Severity (CGI-S) 25 and the mean score of Clinical Global Impressions-Improvement scale (CGI-I) 25 . We defined response as a ≥ 50% reduction from baseline VAS-Mood scores and a Clinical Global Impressions-Improvement CGI-I item score of 1-very much improved or 2-much improved. Remission was defined as a VAS-Mood score less than or equal to the baseline mean follicular phase score. More details about instruments used are given in clinical trial methodology. subject selection This was a naturalistic fixed-dose, non-placebo controlled study aimed to assess the efficacy and tolerability of escitalopram in women with PMDD. Eligible patients included 18 women aged 21-44 years with regular menstrual cycles (duration between 22-35 days) and confirmed PMDD (DSM-IV-TR)1. Symptoms of the disorder must have been present in at least 9 out of 12 menstrual cycles over the previous year. To confirm the diagnosis of PMDD, subjects were required to prospectively rate their symptoms using daily diaries (using VASs scale) for 2 cycles prior to baseline (requirements of DSM-IV-TR) 1 . Subjects were considered eligible for the study if the onset of severe premenstrual symptoms during the luteal phase was followed by symptom subsidence during the follicular phase based on the 4 core symptoms of PMDD (irritability, tension, affective lability, and depressed mood). During the reference cycles women were required to demonstrate a 200% luteal phase worsening on 1 core PMDD symptom or a 100% worsening on 2 core symptoms, which included irritability, tension, affective lability and depressed mood (the 4 core items of VASs). Patients must also have had a baseline Clinical Global Impressions-Severity of Illness scale (CGI-S) score of ≥ 3 ( for the luteal phase) 25 . Patients were considered ineligible if they met DSM-IV-TR criteria for other important psychiatric disorder in the previous 12 months, were diagnosed with gynaecological or other clinically significant disease, presented significant risk for suicide, were already taking medication for PMDD symptoms, or were breastfeeding or pregnant. Use of oral or systemic contraception during the study also precluded participation. All potential patients provided signed informed consent prior to participation. Escitalopram is approved in Romania for the treatment of depressive and anxiety disorders. Patients with suicidal risk represent a psychiatric emergency and are not usually included in clinical studies. Patients with suicidal thoughts should be referred for psychiatric evaluation. study design Eighteen subjects were required to prospectively rate their symptoms using daily diaries (using VASs scale) for 2 cycles prior to baseline. Selection Vol. 4, Nr. 4 /decembrie 2008
criteria were described in the subject selection section. No medication was administered during the first 2 reference cycles. Patients who successfully completed 2 consecutive reference cycles and met all entry criteria have begun the treatment with escitalopram, once daily in the morning, continuously throughout the menstrual cycle. Escitalopram was titrated during the first cycle of treatment as follows: 5mg/ day for the first 3 days, then 10mg/day for other 7 days and then 20mg/day. We maintained the 20mg/day dose during the 3 cycles of treatment. We have chosen this dose because of the results in other previous studies, which revealed that 20mg/day seems to be more efficient than 10mg/day11. After the initiation of treatment, study visits were scheduled to occur within the first 5 days of the onset of menses for up to 3 treatment cycles. clinical trial methodology Potential study candidates were evaluated based on inclusion criteria at an initial visit and then asked to rate their symptoms, as mentioned in the study design. VASs is a revised scale made to better reflect the DSM-IV definition of PMDD 23,25 , with 4 core mood symptoms (depressed mood, tension, affective lability, and irritability), and with 7 additional clusters of symptoms (decreased interest in usual activities, difficulty with concentration, lack of energy, change in appetite, change in sleep pattern, feeling out of control, and physical symptoms). The use of VASs as a valid and reliable assessment for mood symptoms is well documented. Each VAS item consists of a 100-mm horizontal line with vertical line anchors at each end. 0 = “not at all” Vol. 4, Nr. 4/decembrie 2008 The anchors were 0 = “not at all” (that is, “the way you normally feel when you don’t have premenstrual symptoms”) and 100 = “extreme symptoms” (that is, “the way you feel when your premenstrual symptoms are at their worst”). VAS data of this type is recorded as the number of millimeters from the left of the line in the 0-100 range 23 . Participants completed a self-rating set of 11 VASs daily throughout 5 menstrual cycles (2 pretreatment and 3 treatment cycles). Every score was calculated in the screening (pretreatment) period for diagnostic purposes and inclusion criteria. The scores were also calculated in the 3 cycles of treatment. The VAS scores on the 4 core symptoms were averaged to create a mean score to represent mood symptoms that is, VAS Mood score. This was the primary efficacy variable. We have also calculated the VAS total scores (average of 11 symptom scores) and the mean luteal phase VAS physical symptoms. Other efficacy assessments used included The Clinical Global Impressions Severity CGI-S, The Clinical Global Impressions-Improvement scale (CGI-I) 25 and The Montgomery Åsberg Depression Rating Scale (MADRS) 24 . The Clinical Global Impressions (CGI) Scale is a standardized assessment tool 25 . The CGI-S assesses the clinician’s impression of the patient’s current illness state. Scores on the CGI-S range from 1 = not ill at all to 7 = among the most extremely ill. The CGI-I assesses the patient’s improvement or worsening from baseline, which here is the beginning of the treatment (the second reference cycle). The CGI-I also goes from 1 = very much improved to 7 = very much worse 25 . The Montgomery Åsberg Depression Example of the first item of VASs Depressed mood “the way you normally feel when you don’t have premenstrual symptoms” 100 = “extreme symptoms” “the way you feel when your premenstrual symptoms are at their worst” Rating Scale is a well-known psychiatric scale for depression with 10 items rated from 0 to 6. A score of 10 is used as a cutoff point to suspect a depression 24 . Vital signs, laboratory data, and adverse events data were also collected during the study. statistical methods For each of the individual VASs items, the patient’s mean score was calculated for each luteal phase by averaging the item score over the last 5 days of the luteal phase prior to onset of menstruation. The patient’s mean luteal phase VAS-Mood score was then calculated as the mean of the luteal phase core ( first 4 items) scores. We calculated also the VAS total scores (total of 11 symptom scores), the mean luteal phase VAS physical symptoms, the mean total MADRS scores and the mean CGI-S and CGI-I scores. To determine the proportion of patients in remission (defined as a VAS- Mood score less than or equal to the baseline mean follicular phase score), we calculated the mean baseline VAS-Mood at the baseline visit, and compared it with the mean VAS-Mood at the visit of the third of treatment cycle. By subtracting a baseline score from the corresponding score at each treatment visit (1, 2 and 3 of treatment period), derived the change score. This study was a naturalistic one and the number of patients was not sufficient to make other statistical measurements. Results and discussions Patients and baseline data This study was carried out in one outpatient centre. Eighteen patients were selected by symptoms criteria, were then screened for 2 consecutive cycles through daily diaries using VASs, have met all of the inclusion criteria and started the treatment. The mean age at study entry was 34. Mean baseline VAS-Mood score in the luteal phase was 59.07 mm, while in the folicular phase was 8.42 mm (Table 1). Mean MADRS score at baseline was 26.7 (Table 1). There were no marked differences at baseline between patients with respect to severity of PMDD symptoms as measured by the global assessments. Global assessments of disease severity at baseline in the luteal phase pag. 255 gineco ro
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